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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Optiflow Nasal Filtered Interface with CO2 Sampling Medium
FISHER & PAYKEL HEALTHCARE LIMITED
AA031JM
In Commercial Distribution

  • 09420012470959 ()
  • 09420012470942 ()

  • MEDIUM
AA031JM

  • Nasal oxygen cannula, basic
Adult Optiflow Heated Circuit Kit
FISHER & PAYKEL HEALTHCARE LIMITED
950A40J
In Commercial Distribution

  • 09420012461223 ()
  • 09420012461117 ()
950A40J

  • Ventilator breathing circuit, single-use
TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution

  • 00618474000046 ()


  • Skin regeneration template, human-/animal-derived
Dual cure semi-permanent luting cement
Harvard Dental International GmbH
7081400
In Commercial Distribution

  • EHAR70814001 ()


  • Dental composite resin
Dual cure semi-permanent luting cement
Harvard Dental International GmbH
17720
In Commercial Distribution

  • EHAR177201 ()


  • Dental composite resin
Syva® Emit® 2000 Sirolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445402
In Commercial Distribution

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator
Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445008
In Commercial Distribution

  • 00842768016912 ()
  • 00630414017105 ()
RC423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10445194
In Commercial Distribution

  • 00842768016714 ()
KC660

  • Multiple thyroid marker IVD, calibrator
Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator
Cyclosporine Extended Range Calibrator, 3x2mL / 3x1.5ml
Siemens Healthcare Diagnostics Inc.
10445186
Not in Commercial Distribution

  • 00842768016448 ()
KC440

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control
Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-013A2
In Commercial Distribution

  • E12013A2 ()
  • EFSM12013A20 ()


  • Dental composite resin
Semi-Permant Cement for Crowns and Bridges on Implants
First Scientific Dental Materials GmbH
12-008
In Commercial Distribution

  • EFSM120080 ()


  • Dental composite resin
Dual Cure Flowable Composite Cement
First Scientific Dental Materials GmbH
12-005A3
In Commercial Distribution

  • EFSM12005A30 ()


  • Dental composite resin
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-001A3
In Commercial Distribution

  • EFSM12001A30 ()


  • Dental composite resin
Dual Cure Translucent Temporary Cement
First Scientific Dental Materials GmbH
32-001
In Commercial Distribution

  • EFSM320010 ()


  • Zinc oxide eugenol dental cement
Premium Dual cure Core Build-up and Post Cementing Composite
First Scientific Dental Materials GmbH
12-001BLUE
In Commercial Distribution

  • EFSM12001BLUE0 ()


  • Dental composite resin
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